In recent years, great advances in the design, manufacture and uses of medical devices have provided patients with enormous benefits during surgery and treatment. Single-use devices (SUDs) are one of them.
While initially SUDs such as single-use syringes were developed at the request of healthcare providers to limit infection and cross contamination, they are today often miniaturised high-performance devices. They are available as single-use devices only, due to the critical performance and sterility needs.
However, some important safety, ethical and legal issues arise when such devices, originally designed and labelled for single use, are reused in violation of the manufacturers’ express instructions. In other words, these devices have been used, then refurbished (disassembled, cleaned, reassembled, sterilised and repackaged) and reused, often on another patient.
WHAT IS A SINGLE-USE DEVICE?
An SUD is a device intended and designed to be used only once on a single patient. ‘Intended use’ means use according to the data supplied by the manufacturer and appearing on the label, in the instructions for use and/or in promotional materials. A single-use device is delivered sterile, is used and must then be discarded.
The use of advanced designs and materials in medical devices involves a number of key issues concerning their practical use. In particular, the use of these devices on multiple patients, their cleaning and sterilisation, and the deterioration of their performance after their first use are important considerations. These aspects of the design and manufacture of a medical device prompt the decision whether to designate it as a multiple or single-use device. Therefore, SUDs and reusable/multiple-use devices belong to two distinctive categories.
Single-use devices are not designed to be reprocessed or reused, whereas reusable devices have been designed in such a way that they can be practically fully refurbished and, more importantly, safely refurbished. After all of these processes, the devices return to what their original specified condition and performance is intended to be.
In the case of single-use devices, by definition, these processes would have to be carried out without any validated evidence from the manufacturer that the device will still effectively perform its intended function.
POTENTIAL PATIENT HAZARDS
Today, it is impossible to guarantee that all tissue, blood and body residues have been completely removed after refurbishing single-use devices. As a result, a series of non-neglectable issues, which can jeopardise their safety and functionality, can be encountered.
Reusing single-use devices can lead to potentially serious consequences for the patient: cross infection, injury, diagnostic errors and ineffective care. By risking possible contamination and infection within hospitals, it also has a dangerous impact on public health in general.
In addition to the potential risks this practice can cause, its ethical aspects also have to be taken into consideration. The patient is the ethical centre of healthcare. It is a basic principle of medical treatment that patients should consciously agree to the form of treatment, particularly if it involves surgery and puts them at risk. That consent should ‘be informed’.
However, it seems that in countries where the reuse of single-use medical devices is tolerated, patients are not told that they will be treated with a product reprocessed against the manufacturer’s instructions, or informed of the related risks. Most of the time, clinicians are often unaware about the decision taken by hospitals to reprocess SUDs and are equally unaware that they are exposed to liability as a result.
BENEFITS VS CONSEQUENCES
Many hospitals in Europe are reusing SUDs under the pretence that it saves money and because they believe it benefits the environment. With pressure growing to keep healthcare budgets under control, reprocessing of single-use medical devices is becoming increasingly tempting.
While using SUDs benefits the patients by making faster, more efficacious and less risky procedures possible, and by contributing positively in the eradication of hospital acquired infections, reusing them strongly reduces their benefits by compromising patients’ and hospitals’ safety. In case of malfunctioning, consequences which can lead to important hidden costs should be considered.
All of these consequences have also a cost for hospitals and should therefore be taken into account. As far as ecological considerations are concerned, it is to be noted that reprocessing involves the use of powerful detergents, disinfectants, solvents and plastics, which all end up as waste products.
LACK OF REGULATION
Current EU directives do not tackle this practice, since the reprocessing of SUDs happens after the placing of devices on the market which is, in principle, under the jurisdiction of the member states. As a result, different ways of facing the issue occur in European countries.
In France, a law banning the reuse of any SUD was published in June 2001, whereas in Germany no law either regulates or bans it. On the other hand, German legislation requires reprocessors of reusable devices to give proof that the reprocessing procedure is safe. German law, furthermore, provides for strict guidelines for the documentation and validation processes of the device to ensure the safety of patients, users and third parties.
It is questionable that applying the same procedures without taking into account the differences between reusable and single-use products may lead to the same results. Spain, Italy and Portugal have formally, or through the interpretation of their local Health Authority, banned the reuse of SUDs. The UK has issued a strong statement cautioning against reuse, while in Belgium, the political debate to allow reprocessing remains lively.
Outside Europe, in the US and in Australia, the practice is regulated; and the WHO even condemns it.
As a general rule, most other countries provide limited or no regulatory framework to determine efficacy of the reprocessing.
While reuse of single-use medical devices should clearly be prohibited, if this practice is nevertheless tolerated, the explicit consent of the patient should be required in every case.
Furthermore, the reprocessors should be able to guarantee that the single-use devices they are reprocessing will perform to their original standards, in order for patients to have access to the same level of quality of medical treatment, regardless of resources.
In the latest revision of the Medical Device Directive (MDD), the Council of Ministers adopted a paragraph covering the urgent actions that have to be taken regarding the reuse of SUDs. Currently, the Commission is evaluating the whole situation and will be commenting on it in the coming months.
In due time, it will be interesting to see what the Commission will propose and, depending on what will come out of it, to focus on what can and has to be done.
Further discussions with all the actors involved in this issue will be more than needed and necessary. All stakeholders are expected to think first of the health and safety of patients.